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EPIK-B5: alpelisib plus fulvestrant versus placebo plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer after aromatase inhibitor and CDK4/6 inhibitor
2023-509133-39-00Phase 3Authorised
- Sponsor
- Novartis
- Start
- Nov 2021
- Modality
- Small Molecules
- Countries
- 18
01
Overview
Phase 3, randomised, double-blind trial in breast cancer comparing Alpelisib + fulvestrant with Placebo + fulvestrant (2 arms). Primary endpoint: Progression-free survival. Planned start Nov 2021; status: authorised.
02
Drugs
alpelisibfulvestrant
03
Conditions
breast cancer
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